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Drug

Follitropin beta

Approved · EMA

Late-stage development

Also known as Follistim, PUREGON, Folitropina beta, Follitrophin beta+2 more

Follistim, PUREGON, Folitropina beta, Follitrophin beta, Recombinant human follicle stimulating hormone beta, follitropin beta,recombinant.

1

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI on the Expression of FSH- and LH-receptors in Granulosa Cells

Clinical trial2024-06-30Completed · ClinicalTrials.gov

Reduction of Progesterone Elevation at Trigger in Poor Responder Bologna' Criteria Patients After Controlled Ovarian Stimulation With Long Acting Standard Stimulation Protocol Compared With Conventional Daily Protocol: a Single Center Prospective Randomized Fase IV Trial

Clinical trial2024-05-06Completed · ClinicalTrials.gov

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Assessing the Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women Undergoing an Assisted Reproductive Technology Programme

Clinical trial2023-08-24Results posted · ClinicalTrials.gov

A Comparison Between Corifollitropin Alfa and Recombinant FSH for Follicular Recruitment in Women With Polycystic Ovaries Who Undergo IVM Treatment

Clinical trial2022-12-31Completed · ClinicalTrials.gov

An Efficacy and Safety Study of Corifollitropin Alfa Versus Daily Follitropin Beta for Controlled Ovarian Stimulation in Women 35-42 Years Old With a Body Weight ≥ 50 kg Undergoing IVF Treatment.

Clinical trial2017-08-15Completed · ClinicalTrials.gov

Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct and GnRH Agonist Trigger for Egg Bank Donation

Clinical trial2017-03-08Completed · ClinicalTrials.gov

A RCT Study to Evaluate the Safety and Efficacy of the Fixed Day-5 Antagonist Protocol Versus the Flexible Antagonist Protocol for the Controlled Ovarian Stimulation in Chinese Women With Predicted High Ovarian Response

Clinical trial2016-12-01Primary completion · ClinicalTrials.gov

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Japanese Women Undergoing an Assisted Reproductive Technology Programme

Clinical trial2016-09-01Completed · ClinicalTrials.gov

Corifollitropin Alfa (Elonva) Versus Follitropin Beta in High Responders: A Randomized Controlled Trial

Clinical trial2016-09-01Primary completion · ClinicalTrials.gov

Time-lapse Monitoring of Early Embryo Development After Ovarian Stimulation During Infertility Treatment

Clinical trial2015-01-01Terminated · ClinicalTrials.gov

A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in Polycystic Ovarian Syndrome (PCOS) Patients

Clinical trial2012-01-27Results posted · ClinicalTrials.gov

Approval: Puregon (EMA)

Regulatory1996-05-02EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Follitropin beta

Aliases & brands

FollistimPUREGONFolitropina betaFollitrophin betaRecombinant human follicle stimulating hormone betafollitropin beta,recombinant

RxNorm CUI

25357

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

1996-05-02

Latest approval

1996-05-02

Authorities

EMA

Total events

1

emaEuropean Medicines Agency· 1 event

1996-05-02Approval

Approval: Puregon (EMA)

Indication: In the female: Puregon is indicated for the treatment of female infertility in the following clinical situations: anovulation (including polycystic ovarian syndrome, PCOS) in… Show full indication

In the female: Puregon is indicated for the treatment of female infertility in the following clinical situations: anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate; controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs (e.g. in-vitro fertilisation / embryo transfer (IVF/ET), gamete intrafallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)). In the male: Deficient spermatogenesis due to hypogonadotrophic hypogonadism.

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

14 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

14

registered trials across all phases

LATEST COMPLETION 2024

11

Late-stage (III+)

11

Completed

3

Discontinued

PHASE DISTRIBUTIONn = 14

Phase 11Phase 22Phase 32Phase 47Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Reduction of Progesterone Elevation at Trigger in Poor Responder Bologna' Criteria Patients After Controlled Ovarian Stimulation With Long Acting Standard Stimulation Protocol Compared With Conventional Daily Protocol: a Single Center Prospective Randomized Fase IV Trial

CompletedPH IVIRCCS San Raffaelen=1102024

An Efficacy and Safety Study of Corifollitropin Alfa Versus Daily Follitropin Beta for Controlled Ovarian Stimulation in Women 35-42 Years Old With a Body Weight ≥ 50 kg Undergoing IVF Treatment.

CompletedPH IVVietnam National Universityn=4002017

Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct and GnRH Agonist Trigger for Egg Bank Donation

CompletedPH IVMichigan Reproductive Medicinen=382017

Corifollitropin Alfa (Elonva) Versus Follitropin Beta in High Responders: A Randomized Controlled Trial

Unknown statusPH IVEugonian=622016

A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in Polycystic Ovarian Syndrome (PCOS) Patients

CompletedPH IVFerring Pharmaceuticalsn=1102010

Recent completions

Trials that read out recently, adding to the completed evidence base.

Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI on the Expression of FSH- and LH-receptors in Granulosa Cells

CompletedPH IART Fertility Clinics LLCn=62024

Reduction of Progesterone Elevation at Trigger in Poor Responder Bologna' Criteria Patients After Controlled Ovarian Stimulation With Long Acting Standard Stimulation Protocol Compared With Conventional Daily Protocol: a Single Center Prospective Randomized Fase IV Trial

CompletedPH IVIRCCS San Raffaelen=1102024

A Comparison Between Corifollitropin Alfa and Recombinant FSH for Follicular Recruitment in Women With Polycystic Ovaries Who Undergo IVM Treatment

CompletedPH IIIUniversitair Ziekenhuis Brusseln=1452022

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Assessing the Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women Undergoing an Assisted Reproductive Technology Programme

CompletedPH IIIFerring Pharmaceuticalsn=3732019

An Efficacy and Safety Study of Corifollitropin Alfa Versus Daily Follitropin Beta for Controlled Ovarian Stimulation in Women 35-42 Years Old With a Body Weight ≥ 50 kg Undergoing IVF Treatment.

CompletedPH IVVietnam National Universityn=4002017

Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct and GnRH Agonist Trigger for Egg Bank Donation

CompletedPH IVMichigan Reproductive Medicinen=382017

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.